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1 Superficial Femoral Artery: Which h Factors Influence Patency? Oscar A. Mendiz.MD.FACC.FSCAI Chairman hi of Interventional Cardiology dil March 2010 Name: Oscar A. Mendiz Disclosure I have the following potential conflict of interest: Cordis: Advisory Board, Grant Research, Speaker. BSCI: Grant Research Elli Lilly; Speaker. Medtronic, Speacker. Braile Biomedica: Family representation Meetings Sponsorships: BSCI, Cordis, Acher (Cook), Medikar (ClearStream), Angiocor (AGA), BioSud (Abbott), Sanofi.

2 Restenosis Rate after PTA/Stenting of Peripheral larteries Internal carotid artery 2.5-5% Iliac arteries 5-15% Renal arteries 10-20% Fem-Pop 35-75% Below-the-knee 25-75% SFA Restenosis: Predictors Clinical features: Diabetes Tabaquism End stage Renal Failure Inflammation ( CRP) 1 Angiographic: g TASC C (stenosis >15cm) Procedural related: TASC D (CTSO >20 cm) Diffuse disease Severe calcification (suboptimal results) Poor run-off 2 Suboptimal results ( residual stenosis) Balloon vs. Stent 3 Stainless Steal vs. Nitinol Stent 3 Stent length Stent fracture 1 Shillinger M, et al. Radiology 2002 Oct:225(1): Davies MG, et al. J Vasc Surg May kawamura I, et al. J Vasc Surg Nov;50(5):

3 Balloon Angioplasty versus Implantation of Nitinol Stents in the Superficial Femoral Artery Restenosis Angiografía a 6 meses Duplex scan Schillinger M, et al. NEJM 2006;354: Freedom from 2 Years 100 m from TV VR(%) Cumulativ ve Freedo Log Rank p= % 46.2% Stent PTA Stent PTA (0) (1) 41 (5) 38 (8) 33 (13) 32 (14) 31 (15) 31 (15) 44 (8) 38 (14) 37 (15) 27 (25) 25 (27) 24 (28) 29 (17) 24 (28) Follow-up Time (months) Schillinger M, et al. Circulation 2007;115:2745

4 Bare Stent vs. POBA: 12-months restenosis at Randomized d trials Self-Expanding nitinol stents in the FP segment: technique and mid-term results Restenos sis Free Surviv val Months Mewissen, MW. Tech Vasc Int Radiol 2004;7:2-5

5 Bare Stent TLR at 12 and 24 months Study Stent Inclusion Criteria Durability (Bosiers 2009) n=134 FAST (Krankenberg 2007) n=127 Resilient: (Katzen ISET 2008) n=153 Protégé EverFlex Luminexx Stent 15% at 12 months No in-stent Lesion Length <14cm Rutherford 2-4 De novo lesions Length 1-10cm, multiple Ls, <10cm total >70%DS No in-stent Lesion Length <15cm Rutherford 1-4 TLR 21% 15% 13% at 12months 20% at 24 months Mechanical Forces in the SFA

6 Stent Fracture and Restenosis X-Ray Sistematic screening. Scheinert D, et al. JACC 2005;45:312-5

7 Stent Fracture and Restenosis X-Ray Sistematic screening. 12 months 48% P< % 80% 27% 60% 40% 20% St With Fracture St Without Fracture 0% Scheinert D, et al. JACC 2005;45:312-5 Stents Vs. Balloon Stent Fracture: ADi Disappointmenti after first enthusiasm Scheinert D, et al. J Am Coll Cardiol, 2005, Jan 18

8 Stents Fracture-Rates of Different Nitinol Stents Stent / Trial Fracture-rate 12-Months Patency Luminexx 52.1% <50% (FESTO-trial) SMART 16.1% 82.1% (FESTO) SMART (Sirocco) 11-31% >80% Absolute (Vienna) 2.0% 63.3% LifeStent (Resilient) 2.0% 80% Everflex (Durability) 8.1% 72.2% Scheinert D, Linc 2010 Which Lesions are we Treating? Maris, multicenter Registry % Lesion Type Lesion Lengh T Zeller, LINC 2010

9 Which Lesions are we Treating? Maris, multicenter Registry Restenosis or reocclusion on duplex US at 373±days by lesion type % T Zeller, LINC 2010 Which Lesions are we Treating? Maris, multicenter Registry Restenosis or reocclusion on duplex US at 373±days by lesion length % T Zeller, LINC 2010

10 Which Lesions are we Treating? Maris, multicenter Registry Univariate analysis on restenosis or reocclusion on duplex US: Diabetes + Gender % T Zeller, LINC 2010 Drawbacks of Current Generation Stents Nor or insufficient axial flexibility (stent design) Suboptimal surface finishing contributing to earlier fatigue. Insufficient stent-length resulting in multiple overlaps. p Patients Drawbacks: Usually treat long and severely calcified lesions.

11 Stent Design improved but not yet optimal EPIC-Stent NovoStent s Alternating ti Helix SAMBA FlexStent SFA; Meta-Analysis: Outcomes of interventions for recurrent disease after endoluminal dl li intervention ti for superficial i lf femoral artery disease. 5 years PTA 66 Surgery Primary Patency Symptoms Relief Morbidity Davies MG, et al. J Vasc Surg May 15.

12 SFA: New strategies to prevent restenosis Atherectomy (debulking pre stent) Cryoplastia Drug Eluting Stent Drug Eluting Balloon Biodegradable-DES First In Man Experience Fava M, et al. JVIR 2004;15:

13 Cryoplasty: y SFA Baseline Acute 6 Months 18 Months Dr Mario Fava Dr Mendiz. ISET FemPac Trial 6-months Restenosis Survival without TLR & amputation

14 THUNDER TRIAL Local Taxan with short time contact for reduction of restenosis in distal arteries Binary Restenosis at 12 months % Patien ntes Tepe G, et al, Thunder Trial. N Eng J Med 2008;358: THUNDER TRIAL Local Taxan with short time contact for reduction of restenosis in distal arteries Late Lumen Loss at 6 Months % Patien ntes Tepe G, et al, Thunder Trial. N Eng J Med 2008;358:

15 Drug Eluting Balloons: Is Additive Necessary? Drug Eluting Stents: SIROCCO SFA Stenting Study SIROCCO I n=36 SIROCCO II n=57 Sirolimus Control Sirolimus Control Estenosis >70% de 7-20 cm Estenosis >70% de cm Oclusiones de 4-20 cm Oclusiones de cm Smart stent de 8 cm Smart stent de 8 cm Máximo 3 Máximo 2

16 SIROCCO I SIROCCO SFA Stenting Study SIROCCO II Reestenosis angiográfica a 6 meses Sirolimus Control Sirolimus Control % 0 7.7% Reestenosis Duplex scan 9 meses 9.7% 14.3% Reestenosis Duplex scan 18 meses 33.3% 29% Reestenosis Duplex scan 24 meses Drug Eluting Stents: Zilver PTX Scheinert D, europcr 2010

17 Zilver PTX Single arm registry Patency (PSVR <2.5) Stent fracture: 22/14432 St 1.5% Scheinert D, europcr 2010 Drug Eluting Stents: Zilver PTX Literature Comparisons Comparison of Silver PTX Single-Arm Study subsets Matched with published data show: Improved 12-months patency rates with Zilver PTX Close to 50% restenosis rate reduction with Zilver PTX Modified from Scheinert D, EuroPCR 2010

18 Bioabsorbable, DES (?): Conclusions: Using current technology we can treat more complex lesions. Stent restenosis rate at SFA is still high. Bare stent are superior than POBA. Current stent technology is not ideal. Cryoplatia and Drug Eluting Balloon seems promising but not definitive. New stent design are warranted.

19 Nevertheless.: Restenosis is better than amputation

20 SFA; Challenging environmental for Stent: Durability??:

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